A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of two doses of ACT-128800, an oral S1P1 receptor agonist, administered up to twenty-eight weeks in patients with moderate to severe chronic plaque psoriasis

Phase 1

• Conditions: Moderate to severe chronic plaque psoriasis; MedDRA version: 12.1 Level: LLT Classification code 10037153 Term: Psoriasis

• Registration Number: EUCTR2010-019283-36-GB
• Lead Sponsor: ACTELION Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-03
• Study Completion: 2012-10-24
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 320

Inclusion Criteria

• Adult males and females aged 18 to 60 years (inclusive) with moderate to severe plaque psoriasis who require systemic treatment.
• Patients achieving at least PASI50 at Week 16 are eligible to continue participating in the study up to week 28 (maintenance period).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis.
• Systemic or topical treatments for psoriasis other than emollients.
• Ongoing bacterial, viral or fungal infections.
• History or presence of malignancy.
• Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate at Week 16 (the end of the induction period) the efficacy of at least one of two doses of ACT 128800 compared to placebo in patients with moderate to severe chronic plaque psoriasis based on the proportion of patients with at least 75% improvement of Psoriasis Area and Severity Index (PASI) from baseline to Week 16.;Secondary Objective: To assess at Week 16 (end of the induction period) the efficacy of two doses of ACT 128800 compared to placebo based on the improvement of Physician’s global assessment (PGA) from baseline to Week 16.;<br> Primary end point(s): Primary efficacy endpoint:<br> Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.<br>